US8337475B2 - Corporeal drainage system - Google Patents

Abstract

A corporeal drainage system including a fluid receptacle. The fluid receptacle in one embodiment is disposable and may be manipulated to generate a negative fluid pressure. The fluid receptacle in another embodiment is reusable and includes features to enable the insertion of a disposable bag therein. A pump may be integral to the fluid receptacle, the pump including a pair of unidirectional check valves. A catheter connection system is described, which facilitates connection between a fluid flow conduit and an implanted catheter. Methods of producing active and passive siphon systems are also disclosed.

Description

PRIORITY

This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/617,758, filed Oct. 12, 2004, which is expressly incorporated by reference as if fully set forth herein.

BACKGROUND OF THE INVENTION

Fluid accumulation due to sickness or trauma may develop in areas within a mammalian body not designed to accommodate such accumulation. One particular area prone to abnormal accumulation is between sheets of tissue covering the outside of the lung and lining the chest cavity, known as the pleural space. While a normal functioning pleural space contains approximately 5-20 mL of fluid, fluid turnover occurs on an hourly basis such that approximately 5-10 L of fluid passes through the pleural space every day. Thus, any disruption in fluid turnover may result in over-accumulation of fluid in the pleural space, known as pleural effusion. The symptoms of pleural effusion include dyspnea, tachycardia, cough, breathing difficulty and chest pain as the lungs are prevented from fully expanding upon breathing. Pleural effusion is a condition secondary to trauma, cancer, nephrotic syndrome, kidney disease, pancreatitis, congestive heart failure and cirrhosis, and as such, patients affected with pleural effusion will usually die within three months of onset. Consequently, treatment of pleural effusion is generally provided for patient quality of life in his/her final days.

There are numerous methods to treat pleural effusion and/or other unwanted fluid accumulation in a mammalian body. Fluid drainage procedures, such as thoracentesis, may be used to provide patient relief. Thoracentesis involves the introduction of a needled catheter into the pleural space through an incision in the chest cavity, after which fluid is drawn out using a syringe or a vacuum source. Drawbacks with this procedure, however, include the fact that the needle may inadvertently puncture a lung, leading to aggravation of the problem, and the fact that fluid readily re-accumulates in the pleural space after the procedure is performed such that it may become necessary for a patient to undergo the procedure every few days. Pleurodesis is a procedure in which fluid is prevented from accumulating due to the sealing of the space between pleura with either sterile talc or an antibiotic, after first draining the existing fluid. Another method to treat pleural effusion is to surgically implant a chest tube or catheter such that fluid accumulation can constantly or periodically be removed without invasive surgery. The implanted catheter may be connected to an external catheter or drainage tube by a one-way valve mechanism, which permits fluid drainage through the use of a negative pressure source, such as a vacuum. One example of such a catheter system is described in U.S. Pat. No. 5,484,401 to Rodriguez et al., which is expressly incorporated by reference as if fully set forth herein.

While catheter-based systems have been described in the prior art, and indeed are being utilized by patients in the US, significant drawbacks exist. For example, although effective and clinically acceptable, existing catheter-based systems suffer from one or more of the following deficiencies: 1) the catheter/drainage tube connection is not secure and can be easily pulled apart (while not life threatening, accidental disconnection will cause loss of vacuum pressure mandating set-up with a new system; also, such disconnects can be the cause of pleural or peritoneal infection); 2) the clamp supplied on the drainage tube is difficult to use and is not an effective means of controlling fluid flow; 3) the system is useless in the event of an accidental loss of vacuum (effective safety mechanisms designed to prevent such accidental or premature loss of vacuum are missing); 4) the clamp sealing the vacuum chamber (which must be removed in order to activate drainage) is difficult for older patients and care givers to detach; 5) the collection chambers provided with the drainage systems (typically 500 mL) are not adequately sized for peritoneal drainage where fluid collection volumes can reach 2000 mL.

Thus, there is a need for an improved system for corporeal drainage, which will provide beneficial aspects, including those that will facilitate the use thereof regardless of patient location or condition.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a corporeal drainage system, showing a container in an open position for positioning of a disposable fluid collection bag.

FIG. 2 is a perspective view of the corporeal drainage system ofFIG. 1, showing the container in a semi-closed position.

FIG. 3 is a perspective view of the corporeal drainage system ofFIG. 1, showing the container in a closed position.

FIG. 4 is a bottom perspective view of another embodiment of a corporeal drainage system, showing in phantom a latch tab and latch clasp. The fluid receptacle is shown in an expanded state.

FIG. 5 is a top perspective view of the corporeal drainage system ofFIG. 4.

FIG. 6 is a top perspective view of the corporeal drainage system ofFIG. 4, shown in a collapsed state in which the latch tab is connected to the latch clasp.

FIG. 7 is a side plan view of another embodiment of a corporeal drainage system, showing a fluid receptacle in the form of a bottle in an expanded state.

FIG. 8 is a side plan view of the corporeal drainage system ofFIG. 7, showing the bottle in a collapsed state.

FIG. 9 is a perspective view of the corporeal drainage system ofFIG. 8, showing a distal end of a connection tube inserted into a container holding an amount of fluid to simulate the drainage of a bodily cavity.

FIG. 10 is a perspective view of the corporeal drainage system ofFIG. 9, following expansion of the bottle and transfer of the fluid from the container into the bottle.

FIGS. 11-13 are perspective views of the corporeal drainage system ofFIGS. 9-10, illustrating a passive siphoning process.

FIG. 14 is a side plan view of a fluid receptacle for use with a corporeal drainage system, in which the fluid receptacle also is configured to initiate a negative pressure in the system.

FIG. 15 is a longitudinal cross-sectional view of the fluid receptacle ofFIG. 14 in a collapsed state.

FIG. 16 is a longitudinal cross-sectional view of the fluid receptacle ofFIG. 14 in an expanded state.

FIGS. 17A-C illustrate a hand pump for use with a corporeal drainage system, the pumps in the figures all having a bulbous configuration.

FIG. 18 is another embodiment of a hand pump for use with a corporeal drainage system, the hand pump having a tubular configuration.

FIG. 19 is one embodiment of a corporeal drainage system, incorporating the hand pump ofFIG. 18.

FIG. 20 is one embodiment of a corporeal drainage system, illustrating a connection system between an implanted catheter and a fluid flow conduit.

FIGS. 21-26 illustrate various examples of connection systems for use with a corporeal drainage system.

BRIEF SUMMARY OF THE INVENTION

Accordingly, a corporeal drainage system is described herein that provides beneficial aspects to a target user. In one aspect of the invention, a corporeal drainage system utilizes an inline pump that connects to both the implanted catheter and drainage tube via unidirectional check valves. In another aspect, an inline drip chamber is provided for a corporeal drainage system to monitoring drainage from a bodily cavity. In one embodiment, the inline pump made of a transparent material such that it serves the dual purpose of providing both an inline pump and a drip chamber.

In another aspect of the invention, a corporeal drainage system is configured for use as a passive siphoning system, in which a negative pressure is created following initial activation, in order to alleviate work required by a user in operating the system. In one embodiment, following initial activation (e.g., pump is primed, collapsible container is initially expanded from a collapsed state, etc.), the system is positioned at a level below the reservoir or cavity to be drained to create a siphon system where the weight of the fluid in the tubing acts to drag fluid out of the elevated reservoir. In another aspect of the invention, a corporeal drainage system includes a semi-reusable collection system having a multiple use outer rigid container with single use disposable inner plastic collection bag liners that has the capacity to reactivate the required vacuum for use. In still another aspect of the invention, a corporeal drainage system is configured as a single use, low cost collection system with a pre-loaded force, in which the fluid receptacle also acts as a catalyst for producing a negative pressure in the system. In one embodiment the collection system includes a bottle that is locked in a collapsed state for shipping and storing and can be activated by unlocking. In another embodiment, the collection system includes a disposable bag that can be primed or activated to produce a negative pressure, while also serving as a fluid receptacle.

In another aspect of the invention, a corporeal drainage system is provided such that an implanted catheter can be securely connected to an external fluid flow conduit with minimal effort through use of a convenient connection system. In one embodiment, the connection system includes a catheter connector that can be connected to a drainage line connector.

In one embodiment, a corporeal drainage system includes an implantable catheter, a connection tube, a connection system, including a catheter connector attached to a proximal end of the catheter and a drainage line connector attached to a distal end of the connection tube, and a pump, including a first unidirectional check valve and a second unidirectional check valve, wherein the first unidirectional check valve is positioned at one end of the pump to connect the pump to the fluid receptacle and the second unidirectional check valve is positioned at an opposite end of the pump to connect the pump to the connection tube.

In another embodiment, a corporeal drainage system includes a catheter including a catheter connector at a proximal end thereof, a connection tube including a drainage line connector at a distal end thereof, the drainage line connector and catheter connector being configured for sealing attachment to one another, and a disposable fluid receptacle in fluid communication with the connection tube, the fluid receptacle being configured to create a negative pressure within the system upon activation thereof.

A method of draining fluid from a bodily cavity using a corporeal drainage system having a fluid receptacle includes attaching a connection tube to the proximal end of an implanted catheter, initiating a negative pressure in the system such that fluid flows from the bodily cavity in a direction toward the proximal end of the catheter, and placing the fluid receptacle at a level below the bodily cavity.

These and other objectives, embodiments, features and advantages of the present invention will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

The embodiments described herein are directed to a corporeal drainage system designed to effectively provide a user the ability to drain fluid from their body in a non-clinical setting with a minimum amount of effort. The embodiments of the invention generally contain a connection tube having a proximal end that is either detachably or permanently connected to a pump or container and a distal end that is fashioned with a connector device that permits quick, easy and secure attachment to a device or mechanism inserted within a bodily cavity, including, for example, an indwelling device such as an implanted catheter or port. The connector device may be a standard luer connector or other like connectors as known to one skilled in the art. For example, if an implanted catheter has at its proximal end a female needleless injection port, the connection tube can have at its distal end a male luer connector. Particular connection systems to sealingly connect an implanted catheter to a fluid flow conduit in a corporeal drainage system are disclosed in commonly owned U.S. Provisional Application No. 60/720,443, filed Sep. 26, 2005, entitled “Catheter Connection System,” the complete contents of which are expressly incorporated by reference as if fully set forth herein.

The connection tube may be made of polyurethane or other material known to one skilled in the art suitable for a bodily fluid conduit. The connection tube should be of sufficient length to accommodate all users, such that the container may be placed on the ground or at a location beneath the cavity to be drained without undue discomfort. If the system is configured with a connection tube that is detachable from the container, different lengths can be provided by the treating clinician depending on height of the user and/or other parameters, such as likely location for the draining operation, length of the catheter extending outside of the patient's body, etc. Currently, the standard contemplated length of the connection tube is in the range of approximately 3 ft to 5 ft. The implanted catheter may be any standard medical catheter suitable for insertion into a bodily cavity, having at its proximal end a connector that attachably cooperates with the connector device attached to the connection tube (e.g., male or female luer connector). For example, suitable catheters include peritoneal catheters, thoracic drainage catheters, etc. Moreover, in the embodiments of the invention, a fluid receptacle, which may take the form, for example, of a container, disposable bottle and/or disposable bag can hold approximately 1 L of fluid, although certainly a wide range of volume capability is contemplated for the fluid receptacles of the present invention (e.g., in the range of approximately 0.5 L to 5 L).

Referring now toFIGS. 1-3, acorporeal drainage system10 includes avacuum pump12, a vacuum box/container14, adrainage bag16 and aconnection tube30. Theconnection tube30 is as described above. Thevacuum pump12 may include aflexible membrane20 and a pair of one-way check valves22 (FIG. 3) and can be fashioned in various shapes and sizes. The one-way check valves22,24, may be any type of unidirectional flow valve as is well-known to one skilled in the art. Thevacuum pump12 is operatively associated with the container via a first one-way check valve22, which permits evacuation of air while maintaining a vacuum as it is created within thesystem10. In particular, the first one-way check valve22, permitting movement of air from the container, connects thevacuum pump12 to thecontainer14. A second one-way check valve24, positioned on thevacuum pump12, permits release of air from thepump12. Thus, creation of a negative pressure in thesystem10 includes first activating thepump12 through compression thereof (e.g., pressing downward on the flexible membrane20), which evacuates the air inside thevacuum pump12 through thesecond check valve24 positioned on thepump12, and second releasing the pump12 (e.g., removing the applied pressure from the flexible membrane20), which permits expansion thereof by pulling air from thecontainer14 through thefirst check valve22.

The vacuum pressure provided to thesystem10 is dependent on a number of factors, such as, for example, the number of times thepump12 is activated (e.g., the number of times pressure is applied to theflexible membrane20 and subsequently released), which can be varied based on the type of material used and the surface area of the pump12 (rebound force of the pump (F)/surface area (A)=pressure (P)). Literature suggests that a negative pressure of approximately 30 mm Hg is the maximum that most bodily cavities in mammals are capable of withstanding. Thus, with such a relatively small amount of pressure demanded for the system, the volume of the pump and the material choice for the pump, including wall thickness and durometer, must be carefully considered so that a balance is struck between the number of pumps needed and amount of force necessary for a single activation of the pump. Such selection of wall thickness and durometer will also permit one to control the negative pressure placed into the system, which can be limited to provide a safety function (i.e., the amount of negative pressure possible can be limited by material selection such that even if the maximum amount was achieved by the user, said amount would not exceed the maximum permissible for the bodily cavity to be drained). Given the fact thatsystem10, and other systems described herein, will likely be used by patients with diminished strength and energy, these considerations can play an important role in the design of the system. In an exemplary embodiment, theflexible membrane20 ofpump12 is made of 55 Shore A polyvinylchloride with a wall thickness in the range of approximately 0.05 in to approximately 0.5 in.

In order to maintain a consistent flow of fluid from the bodily cavity in prior art systems, the pump needs to be activated at least intermittently by the user. As previously mentioned, however, the target user may be unable or unwilling to do so. Thus, an advantage of the system described herein is that it is designed with the ability to act as a siphon after initial activation. Specifically, once the user has activated the pump a few times (e.g., in thesystem10 described above, when the user has collapsed theflexible membrane20 and subsequently allowed air from the system to re-expand it two or more times), the user may then place the container (e.g., container14) on the ground (or any location below the body cavity from which drainage is taking place), which effectively creates a passive siphon system that utilizes the weight of the fluid within the catheter and/orconnection tube30 to pull fluid out of the bodily cavity (elevated reservoir). This ability to create a passive system requires only minimal effort from the user, which allows the system to be used in a non-clinical setting by a wide range of users, regardless of physical condition.

The vacuum box/container14, while illustrated in a rectangular box form, may take on virtually any shape. Thecontainer14 may include alid18 that is hinged to a body, as shown inFIGS. 1-3, in order to simplify the removal and installation of adisposable bag16, although many configurations without a hingedlid18 are also possible and within the scope of the invention as would be apparent to one skilled in the art. Due to the configuration of thesystem10 that includes adisposable bag16, the system can be used numerous times. An aperture configured for passage of theconnection tube30 is positioned on a side of the container, having associated with it agrommet26 made of a material, such as silicone rubber, to provide a sealing function for the aperture. In one embodiment, the container also has a gasket positioned around the lid or disposable bag opening such that when said lid or opening is closed, an enhanced seal is provided. Theconnection tube30 is detachable from thecontainer14 in one embodiment to facilitate cleaning of the container14 (seeFIG. 1). In other embodiments, theconnection tube30 is permanently connected to thecontainer14. Thecontainer14 may be made of a rigid plastic material, although many other rigid materials are also suitable, such as, for example, polycarbonate, high density polypropylene, nylon, Lexan®, stainless steel, etc. In the event that the system is designed to be reusable, such as the embodiment shown inFIGS. 1-3, the material choice should be one that may be readily cleaned (e.g., dishwasher safe).

FIGS. 4-6 illustrate another embodiment of acorporeal drainage system40, including adisposable bottle42 made of a material, such as a clear rubber or other elastomer, that serves the dual purpose of acting both as a fluid receptacle and a catalyst or initiator for producing a negative pressure in the system. The term “bottle” as used herein means any type of container that can be filled with fluid, at least a portion of which can be collapsed, at least in part, to evacuate air therefrom. Thebottle42 inFIGS. 4-6 is in the form of a ball, having anactivation knob44 on the exterior of one end and alatch tab48 on the interior of an opposite end. Theactivation knob44 is operatively connected to alatch clasp46 positioned adjacent the knob on the interior of thebottle42. Thebottle42 may be molded in an open configuration and then collapsed for shipping. Upon collapse of thebottle42, thelatch clasp46 and thelatch tab48 connect to lock the bottle in a collapsed condition, pending activation (e.g., by pressing, turning, etc.) of theactivation knob44. In this collapsed state for shipping, the bottle has a pre-loaded force so that unlocking of the latch clasp from the latch tab results in activation of the system with minimal physical effort required of the user.

When the user is ready to initiate drainage of a bodily cavity, theconnection tube30 is attached to an implanted catheter via the connector32 (e.g., luer member), or connection system as described in commonly owned U.S. Provisional Application No. 60/720,443, and theactivation knob44 is activated, unlatching thelatch clasp46 from thelatch tab48 and permitting thebottle42 to expand, pulling fluid from the bodily cavity in the process. In order to generate sufficient force to draw the fluid out of the bodily cavity, the wall thickness of thebottle42 must be carefully considered. In an exemplary embodiment, thebottle42 is approximately the size of a softball, is made of an elastomeric material, and has a wall thickness in the range of approximately 0.05 in. to approximately 0.5 in. In this embodiment, the material of thebottle42 is disposable, such that once the fluid has been extracted from the bodily cavity, thebottle42 can be disposed of; each use requiring a new bottle. In other embodiments, thebottle42 may include an opening such that a disposable bag or other fluid-holding container can be inserted and removed therefrom.

FIGS. 7-13 illustrate another embodiment of a corporeal drainage system, including a bottle. In this embodiment, thebottle52 ofsystem50 includes rigid sides, including atop section54,middle section56 andbase section58, and flexible connecting walls, including first connectingwall62 positioned between thetop section54 andmiddle section56 and second connectingwall64 positioned betweenmiddle section56 andbase section58. The connectingwalls62,64 are configured to collapse within therigid sides54,56,58 upon activation of thesystem50. Thetop section54 has aconnection member60, which is configured to be removably attached toconnection tube30. Bothtop section54 andbase section58 haverespective pull tabs66 and68 attached thereto, the pull tabs functioning to facilitate the expansion of thebottle52, following collapse, upon initiation of a drainage procedure.FIG. 7 illustrates thebottle52 prior to collapse, whileFIG. 8 illustrates thebottle52 following collapse. As is apparent fromFIG. 8, in this embodiment, the connectingwalls62,64 collapse substantially within therigid sides54,56,58 to provide a small profile for storage and shipping.

FIG. 9 showsbottle52 in its collapsed form, as shipped and stored, with theconnection tube30 attached to theconnection member60 at one end with an opposite end inserted into acontainer38 with an amount of fluid therein, which exemplifies the draining of a bodily cavity. As discussed, thesystem50 is activated by pulling on thepull tabs66,68 to expand thebottle52, as illustrated inFIG. 10. The expansion of thebottle52 results in the fluid from thecontainer38 being suctioned into thebottle52. When the bottle is fully expanded, as shown inFIG. 10, a suitable amount of suction has been imparted to thesystem50 such that a majority of fluid from thecontainer38 is transferred to thebottle52. The amount of force required to expand thebottle52 to an expanded state is dependent on a variety of factors, including the material of the bottle, as discussed above. The amount of expansion ofbottle52 necessary to drain a particular bodily cavity is variable and also depends on a number of factors, including the amount of fluid to be drained.FIGS. 9-10 illustrate an active siphoning process, in which the siphoning or transfer of fluid from thecontainer38 to thebottle52 is directly attributable to the expansion of the bottle52 (i.e., the pulling force applied to thepull tabs66,68 as they are pulled in opposite directions). However, the transfer of fluid fromcontainer38 to bottle52 can also be accomplished through a passive siphoning process, requiring much less force. This alternative method of siphoning, for whichsystem50 is also designed, is explained in more detail with reference toFIGS. 11-13.

Through experimentation, it was noted that a pulling force of approximately 20 lbs was required to fully expandbottle52, in order to drain fluid from a bodily cavity. Because such a force requirement may be prohibitive to some users, another method of creating a vacuum was explored. It was discovered that an initial pulling force, significantly less than the 20 lbs necessary to fully expand thebottle52, acted to begin the fluid flow through the catheter and connection tube.FIG. 11 shows thebottle52 in its collapsed state, positioned at the same level as thecontainer38 with a level of fluid therein. In the experiment, once fluid began to enter thebottle52, thebottle52 was dropped to the floor or at a level below thecontainer38.FIG. 12 shows thebottle52 after an initial pulling force, less than 20 lbs, has been applied to the system50 (i.e., thepull tabs66,68 have been pulled in opposite directions), thebottle52 being positioned at a level below thecontainer38. The action of providing an initial pulling force coupled with the action of dropping the bottle below the container generated a siphon within thesystem50, pulling fluid from thecontainer38 and eventually filling thebottle52. As the transfer of fluid from thecontainer38 to thebottle52 takes place, thebottle52 continues to expand until fully expanded as illustrated inFIG. 13.

Thus, the experiment showed that a reduced pulling force, less than the force required to fully expandbottle52, could be utilized with similar results, thereby overcoming the potential problem of requiring a user to provide a larger pulling force than could be achieved by the user. It should be noted that the amount of negative head pressure (i.e., the level or distance of a bottle or container positioned below the drainage reservoir (bodily cavity)) controls the fill rate of the bottle and amount of suction acting on the drainage catheter. Therefore, as the bottle expands and increases in weight, fluid flow rate increases. As such, in one embodiment, a bottle, such asbottle52, is hung or otherwise suspended with a weight attached to the base thereof to increase flow rate. In another embodiment, a bottle is made of a clear material so that, in addition to the audible flow indication, a visual flow indication would be provided to the user.

FIGS. 14-16 illustrate another embodiment of a corporeal drainage system. In this embodiment, system70 includes adisposable bag72 without an associated container, thedisposable bag72 being made of a disposable material so that it serves as a fluid receptacle. Thedisposable bag72 is also configured such that it can be directly manipulated (similar to thebottle52 ofFIGS. 7-13) to produce a negative pressure for the purposes of fluid drainage from a bodily cavity. Thedisposable bag72 is fashioned withrigid members74 attached to opposing sides of thebag72, therigid members72 havingpull tabs76 connected thereto. The rigid surface area of therigid members74 compared to the flexible surface area of the flexible portion ofbag72 is calculated such that a sufficient amount of vacuum can be generated by pulling therigid members74 in opposite directions (thereby expanding the bag).FIG. 14 is a perspective view of the system70, showing one side of thebag72 withrigid member74 andpull tab76, and aconnection member78 attached to one end of thebag72, configured for releasable attachment toconnection tube30.FIG. 14 illustrates a lengthwise cross-sectional view of thedisposable bag72 in a collapsed state prior to initiating drainage (i.e., prior to imparting a negative pressure to the system70).FIG. 15 illustrates a lengthwise cross-sectional view of thedisposable bag72 in an expanded state, following a pulling force being applied to the pull tabs76 (i.e., thepull tabs76 are pulled in opposite directions). As with thesystem50 described above, system70 can be operated as both active (i.e., utilizing only a pulling force to expand the bag72) and passive (i.e., providing an initial pulling force to begin fluid flow and subsequently positioning thebag72 below the level of fluid to be drained).

FIGS. 17-18 illustrate another embodiment of a pump utilized in a corporeal drainage system. In this embodiment, the pump is in the form of a small hand pump (which may be made small enough in size to be considered a “finger pump”) with a rebound area that is able to generate a large suction with a relatively small force.FIG. 17A-C illustrate embodiments of a small hand pump having a bulbous configuration. InFIG. 17A, thepump80 includes a configuration with luer-type connectors at proximal and distal ends to facilitate attachment of the pump in-line to connect a connection tube and fluid receptacle, a connection tube and an implanted catheter, etc. Thepump80 includes two unidirectional valves, one at the proximal end and one at the distal end, to provide the ability of creating a negative pressure in a corporeal drainage system. Thebody82 of thepump80 can be made of a flexible material, such as, for example, silicone.FIGS. 17B and 17C illustrate two variations of thebody82 of thepump80,FIG. 17B having a configuration in which the largest diameter of thebulb body84 is positioned nearer the proximal end than the distal end, andFIG. 17C having a symmetrical configuration in which the largest diameter of thebulb body84 is approximately equidistant from the proximal and distal ends.FIG. 18 illustrates a tubular-shapedhand pump90, requiring a minimal force to begin fluid flow. To initiate fluid flow usinghand pump90, a user grasps between fingers (e.g., between the thumb and index finger) and squeezes one or more times. In one embodiment,hand pump90 has a length in the range of approximately 1 in. to approximately 6 in. and a diameter in the range of approximately 0.25 in. to approximately 2 in. While hand pumps80 and90 are shown in particular configurations, it should be appreciated that many sizes and shapes are possible and would be within the scope of this invention.

The hand pumps80 and90 can be placed in-line into a system, connecting theconnection tube30 to either a reusable container with a disposable bag therein, a disposable bottle, or a disposable bag (e.g., zero volume collapsed bag), as described above. In one embodiment, thehand pump90 is incorporated intosystem100, as illustrated inFIG. 19. A pair of one-way check valves92,94 respectively connect thehand pump90 to theconnection tube30 and the fluid receptacle102 (e.g., container, bottle, bag, etc.). In this embodiment, thehand pump90 is includes a body made from a material that is transparent. Thus, by placing thehand pump90 in-line insystem100, thepump90 also acts as a “drip chamber” so that the user is able to visually monitor the flow of fluid from the bodily cavity to thefluid receptacle102. Operation ofsystem100 includes first activating thehand pump90 by squeezing the sides together and subsequently releasing one or more times (e.g., five or six times), which creates a negative pressure in theconnection tube30 as air is transported through the one-way check valves92,94 in a direction toward thefluid receptacle102 until fluid begins flowing therein. Thereafter, as explained above in connection with a passive siphoning process, thefluid receptacle102 is dropped to a level below the bodily cavity being drained (e.g., placed on the floor). The minimal force required to begin fluid flow insystem100 as described is advantageous to the target user due to strength and stamina concerns discussed above. The relative small size of the system (especially in the case that the system includes a zero volume collapsed bag) facilitates shipping and storage.

As discussed above, the corporeal drainage system may include a connection system for easy, fast and secure connection between an implanted catheter and a connection tube as described herein (e.g., connection tube30). Particular connection systems for the corporeal drainage system described herein are disclosed in commonly owned U.S. Provisional Application No. 60/720,443, filed Sep. 26, 2005, entitled “Catheter Connection System,” the complete contents of which are expressly incorporated by reference as if fully set forth herein. One example of a corporeal drainage system incorporating a catheter connection system is illustrated inFIG. 20, which showscorporeal drainage system110 prior to the initiation of a drainage process, includingfluid receptacle112, pump114, firstfluid flow conduit116, connecting thepump14 to thefluid receptacle112, secondfluid flow conduit118, anddrainage line connector120. Acatheter connector130 is connected to an implantedcatheter140, thecatheter connector130 anddrainage line connector120 being configured to fluidly connectsecond conduit118 tocatheter140, as described more completely in commonly owned U.S. Provisional Application No. 60/720,443. To utilize thecorporeal drainage system110, the connection between thecatheter connector120 anddrainage line connector130 is first established, followed by activation of the system by priming (e.g., squeezing) thepump114 one or more times to initiate fluid flow from a bodily cavity. Thefluid receptacle112 is either initially positioned below the cavity to be drained or is positioned below the cavity to be drained following activation of the system.

FIGS. 21-22 illustrate a connection system according to one embodiment.FIG. 21 shows acatheter connector200 including abody210 defining atapered feature220 and flowapertures230. A sealingelement240 is provided to abut thetapered feature220 to effectively seal theflow apertures230. A retainingelement250 may be provided to resist movement of the sealingelement240 toward adistal end260 of thebody210.FIG. 22 shows thecatheter connector200 coupled to adrainage line connector270. Thedrainage line connector270 includes apositioning sleeve280 and anactuating member290 so that when thedrainage line connector270 is connected to thecatheter connector200, the actuatingmember290 deforms the sealingelement240 away from thetapered feature220 and allows fluid flow through agap225 there between.

FIGS. 23-24 illustrate another example of a connection system comprising a sealing element positioned between at least two components, wherein the components are coupled to one another by at least one hinge clip. The connection system includes acatheter connector300 and adrainage line connector310. Thedrainage line connector310 comprises adrain body320 includinghinge clips330 pivotably affixed to thedrain body320. Each of the hinge clips330 include anengagement feature332 configured to engage acomplimentary coupling feature340 of thecatheter connector300. As shown inFIG. 23, thecatheter connector300 may include aplug body350 that defines atapered feature360. In one embodiment, thetapered feature360 is formed separately from theplug body350. In such a configuration,tapered feature360 may be affixed (e.g., adhesively bonded, ultrasonically welded, solvent welded, or otherwise affixed) to theplug body350. In another embodiment, thetapered feature360 may be formed integrally or monolithically with theplug body350. A sealingelement370 may abut thetapered feature360 to effectively seal abore380 of the sealingplug body350 at one end. A retainingsleeve390 may facilitate coupling of thedeformable sealing element370 to the sealingplug body350. Also, the retainingsleeve390 may extend beyond thedeformable sealing element370 and thetapered feature360 toward thedrainage line connector310. Such a configuration may inhibit inadvertently deforming thedeformable sealing element370. Thedrainage line connector310 may include an actuatingmember395 configured to deform thedeformable sealing element370 upon assembly of thedrainage line connector310 and the catheter connector300 (seeFIG. 24). As shown inFIG. 24, the actuatingmember395 may abut and deform the sealingelement370 away from thetapered feature360 to allow for fluid flow from thebore380 of thecatheter connector300 to abore315 of thedrainage line connector310.

FIGS. 25-26 illustrate yet another example of a connection system comprising acatheter connector400 including abody410 defining aprotruding feature420,apertures430, and asealing element440 positioned between theprotruding feature420 and aclosure element450. The sealingelement440 forms a seal along amating surface460 defining an aperture through theclosure element450. A force F (e.g., generated by an actuating member of a drainage line connector) may be applied to at least a portion of the sealingelement440 to deform the sealingelement440 and allow fluid to flow through agap470 formed between the sealingelement440 and theclosure element450.

In another embodiment of a corporeal drainage system, thedrainage line connector130 is attached to a connection tube, such asconnection tube30, which is connected to a fluid receptacle that also acts as a pump for the system (i.e., the initiator of negative pressure), such as illustrated inFIGS. 4-6,7-13 and14-16 and described above. Use of such a system would begin with attachment of thedrainage line connector130 to thecatheter connector120, followed by activation of the system, as described herein.

This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.

Claims (17)

1. A corporeal drainage system, comprising:

a catheter including a catheter connector at a proximal end thereof, the catheter connector including a tapered feature abutted by a deformable sealing element, the tapered feature in contact with the deformable sealing element in a closed configuration;

a connection tube including a drainage line connector at a distal end thereof, the drainage line connector and catheter connector being configured for sealing attachment to one another, the drainage line connector including an actuating member that deforms the deformable sealing element such that the tapered feature is separated from the deformable sealing element in an open configuration; and

a disposable fluid receptacle in fluid communication with the connection tube, the fluid receptacle being configured to create a negative pressure within the system upon activation thereof.

2. The corporeal drainage system according toclaim 1, wherein the disposable fluid receptacle comprises a bottle including a plurality of spaced apart rigid sides and collapsible connecting walls connecting consecutive spaced apart rigid sides.

3. The corporeal drainage system according toclaim 2, wherein the bottle further comprises a proximal handle attached to a proximal end and a distal handle attached to a distal end, wherein pulling the handles in opposite directions expands the bottle and creates a negative pressure in the system.

4. The corporeal drainage system according toclaim 1, wherein the disposable fluid receptacle comprises a disposable bag.

5. The corporeal drainage system according toclaim 4, wherein the disposable bag includes a first rigid side and a second rigid side, each of the first and second rigid sides including a handle attached thereto.

6. The corporeal drainage system according toclaim 1, wherein the disposable fluid receptacle comprises a bottle including an activation knob.

7. The corporeal drainage system according toclaim 6, wherein the activation knob is operatively connected to a latch clasp, the bottle comprising a latch tab that connects to the latch clasp to maintain the bottle in a collapsed state.

8. A corporeal drainage system, comprising:

catheter means for direct access of a bodily cavity;

conduit means for transporting fluid from the catheter means;

a connection system, including a catheter connector attached to a proximal end of the catheter means, the catheter connector including a tapered feature abutted by a deformable sealing element and a drainage line connector attached to a distal end of the conduit means, the drainage line connector including an actuating member that deforms the deformable sealing element such that the tapered features is separated from the deformable sealing element in an open configuration;

receptacle means for holding fluid drained from the bodily cavity; and

pump means for creating a negative pressure in the system.

9. The corporeal drainage system according toclaim 1, wherein the tapered feature is along an exterior surface of a central shaft of the catheter connector.

10. The corporeal drainage system according toclaim 1, wherein the tapered feature of the catheter connector is tapered such that an end of the tapered feature toward the actuating member of the drainage line connector has a larger diameter than an end of the tapered feature away from the actuating member.

11. The corporeal drainage system according toclaim 1, wherein the deformable sealing element radially circumscribes the tapered feature such that an inner surface of the deformable sealing element contacts an outer surface of the tapered feature.

12. The corporeal drainage system according toclaim 1, wherein the catheter connector comprises a body and a flow aperture between the tapered feature and the body.

13. The corporeal drainage system according toclaim 12, wherein the tapered feature is along an exterior surface of a central shaft of the catheter connector, the deformable sealing element radially circumscribes the tapered feature, and the body is a generally cylindrical shape concentric with the central shaft.

14. The corporeal drainage system according toclaim 1, wherein the deformable sealing element deforms in a longitudinal direction away from the tapered feature by the actuating member to open a gap between the sealing element and the tapered feature.

15. The corporeal drainage system according toclaim 1, wherein the tapered feature linearly increases from a first diameter at a first end to a second larger diameter at a second end.

16. The corporeal drainage system according toclaim 15, wherein the tapered feature is coupled to the catheter connector by a post, the tapered feature oriented such that the first diameter is near the post and the second diameter is away from the post.

17. The corporeal drainage system according toclaim 16, wherein the deformable sealing element is separated from the post by an annular gap and abuts the tapered feature in a closed configuration.

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